BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4190476 · Received October 21, 2014

    Report

    Report Number
    2032227-2014-41276
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 22, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS DISSATISFIED WITH THE VIBRATE FEATURE AND SOUND VOLUME ON THE INSULIN PUMP. THE CUSTOMER STATED THAT THE VIBRATE FUNCTION DID NOT VIBRATE ON ALL ALARMS. HE ALSO NOTED THAT THE MAXIMUM BOLUS LIMIT WAS TOO LOW, SINCE HE HAD LOW SENSITIVITY TO INSULIN. HE STATED THAT HIS INSULIN REQUIREMENTS WERE, SO HIGH THAT HE NEEDED TO EXCEED THE LIMIT EACH TIME AND WOULD HAVE TO BACK OUT OF THE BOLUS WIZARD IN ORDER TO ADMINISTER ADDITIONAL BOLUSES. HE REPORTED THAT HE SOMETIMES WOULD FORGET THE SECOND BOLUS AND HAVE HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER ALSO NOTED THAT HE HAD SET HIS DEVICE TO BEEP LONG, ADVISING THAT HE COULD NOT HEAR IT BUT FELT IT VIBRATE. THE BLOOD GLUCOSE READING WAS UNKNOWN. THE INSULIN PUMP PASSED THE SELF TEST. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666876 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR